| NCT ID | NCT05011877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | Acute Hypercapnic Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-09-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The high frequency of unplanned hospital visits of patients with chronic hypercapnic respiratory failure (e.g., chronic obstructive pulmonary disease, obesity-related hypoventilation) constitutes a major public health problem. Most patients admitted for acute exacerbations (AHRF) have additional comorbidities, especially sleep disorders. Often untreated, sleep disorders contribute to multiple readmissions (≈70% at one year) and increase readmission costs. The investigators will: 1) identify these patients early during unplanned hospital admissions and perform sleep studies using EEG and oximetry before hospital discharge and two months after to compare sleep abnormalities in the two moments; 2) investigate the association between sleep abnormalities in the two sleep studies with clinical outcomes (1-year readmission and death); 3) investigate the acute effects of high-flow nasal cannula (HFNC) to treat sleep abnormalities as a simplified alternative. The investigators anticipate sleep abnormalities during the hospital stay and two months after discharge will be associated with poor clinical outcomes (readmission, death) and HFNC to acutely reduce sleep abnormalities.
Eligibility Criteria
Inclusion Criteria: * Adult patients requiring an unplanned hospitalization or emergency room visit due to an acute hypercapnic respiratory failure exacerbation (AHRF), not on home noninvasive or invasive ventilation, neuromuscular disease (e.g., spinal cord injury) or central nervous system disorders (e.g., cerebral vascular accident, Alzheimer), absence of tracheotomy, and non-morbidly obese. Exclusion Criteria: * Patients with AHRF due to drug overdose * Ventilatory support (noninvasive or invasive ventilation) is needed before or during the sleep studies or if an acute deterioration (e.g., cerebral vascular accident, cardiac arrest) happens before or during the sleep studies.
Contact & Investigator
Laurent Brochard, MD, PhD
PRINCIPAL INVESTIGATOR
Unity Health Toronto - St. Michael's Hospital
Frequently Asked Questions
Who can join the NCT05011877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypercapnic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05011877 currently recruiting?
Yes, NCT05011877 is actively recruiting participants. Contact the research team at Laurent.Brochard@unityhealth.to for enrollment information.
Where is the NCT05011877 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05011877 clinical trial?
NCT05011877 is sponsored by Unity Health Toronto. The principal investigator is Laurent Brochard, MD, PhD at Unity Health Toronto - St. Michael's Hospital. The trial plans to enroll 50 participants.